Tenofovir + Levonorgestrel Vaginal Ring
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Vaginal Ring
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Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): CONRAD
Details
- API: Levonorgestrel, Tenofovir
- Target: Progesterone Receptor, Androgen Receptor, RT
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Mechanism of Action:
- Anti-Microbial
- Inhibition of Sperm Motility
- Inhibition of Sperm Capacitation
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Inactive Materials: Polyurethane
- Regimen: 1 Insertion/90 Days
- MPT: Potential MPT
- Promising Attributes: TFV & LNG are both widely evaluated and used in a number of existing approved products. Vaginal rings are also user controlled, reversable, and minimally invasive.
Product Status
Active/Recent Clinical Research
History
2014: CONRAD publishes formulation/product design information on a dual-purpose HIV prevention + contraception vaginal ring
2018: Phase I Placebo-controlled trial results published, showing an acceptable safety profile and expected biological responses to both TFV and LNG
2019-2022: Vaginal microbiome and mucosal PK analysis conducted
2022: Results from CONRAD 138 study released, introducing additional regime variable (cyclical vs continuous). Qualitative study results on user design feedback released in separate publication.
2023: Results from randomized, controlled Phase IIb trial in Kenya published, confirming that the novel product was safe, well tolerated, and produced biological indicators of both contraceptive and antiviral efficacy.